Flash-melt oral dosage formulation

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/545 (2006.01) A61K 9/00 (2006.01) A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 31/4178 (2006.01) A61K 31/495 (2006.01) A61K 45/08 (2006.01)

Patent

CA 2311734

There is provided granules for the production of flash-melt pharmaceutical oral dosage forms. In addition to one or more medicaments, the granules are composed of an excipient combination consisting of a superdisintegrant, a dispersing agent, a distributing agent, and a binder and may also include other conventional ingredients such as sweetening and flavoring agents. The subject granules are advantageous in that they are stable and can be prepared without the aid of solvents and without the need for special environments or handling. Dosage forms, especially tablets, prepared therefrom on conventional equipment disintegrate in the mouth in under about twenty five seconds.

L'invention porte sur des granules utilisés dans la production de préparations pharmaceutiques orales à dissolution ultra-rapide. En plus d'un ou de plusieurs médicaments, les granules se composent d'un mélange d'excipients constitué d'un superdélitant, d'un agent défloculant, d'un agent assurant la répartition et d'un liant et peuvent aussi comprendre d'autres ingrédients classiques comme des édulcorants et des aromatisants. Lesdits granules sont avantageux car ils sont stables et peuvent être préparés sans l'aide de solvants et sans le recours à un environnement particulier ou une manipulation spéciale. Les formes posologiques, en particulier les comprimés, préparés à l'aide d'un appareillage classique se désintègrent dans la bouche en moins de vingt- cinq secondes.

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